Hexal Ag

Theresa Taeubrich

Patrick Rother

The invention relates to a pharmaceutical composition, comprising or consisting of: 10 to 30 weight percent of at least a pharmaceutically active amount of a pharmaceutical substance selected from the group comprising statins, in particular water-insoluble, oxidatively degradable statins, preferably cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, or combinations thereof, 30 to 70 weight percent of lactose hydrate, 2 to 15 weight percent of microcrystalline cellulose, 5 to 25 weight percent of a partially water-soluble starch, 0.2 to 4 weight percent of at least one alkali and/or alkaline-earth salt of stearic acid and/or stearyl fumaric acid, wherein the composition contains no antioxidatively active substances such as chain terminators, reductants, free-radical scavengers, and complexing agents. The invention further relates to a method for the production thereof, to a composition that can be obtained in the method, and to the use of the pharmaceutical composition according to the invention.

Pharmaceutical statin composition

The invention relates to a pharmaceutical composition for oral administration comprising or consisting of (i) 10 to 30% weight, of at least one pharmaceutically active substance selected from the group consisting of water-soluble, oxidatively-degradable statins, preferably atorvastatin, cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin or a combination thereof, (ii) 0.01 to 3% weight, of a first anti-oxidatively active substance (A1), (iii) 0.01 to 3% weight, of a second anti-oxidatively active substance (A2) that differs from the first anti-oxidatively active substance (A1), and (iv) 60 to 85% weight of at least one additive, selected from the group consisting of filler, binder, flow-regulating agent, disintegrant and anti-blocking agent or a combination thereof, and the use of the pharmaceutical composition in medicine.

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Holzkirchen, Germany

Theresa Taeubrich